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CTRI Number  CTRI/2025/01/079199 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   A clinical study to evaluate heat and moisture exchangers and breathing system filters that are intended to replace the normal warming, humidifying and filtering functions of the upper airways when these structures are bypassed during anaesthesia and intensive care. 
Scientific Title of Study   A prospective study to assess the safety and efficacy of Heat and Moisture Exchange filters and humidifiers in Mechanically Ventilated Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mathangi Krishnakumar 
Designation  Assistant Professor Department of Anaesthesia 
Affiliation  St John’s Medical College Hospital 
Address  Surgical and Neuro Intensive Care unit,2nd Floor St John’s Medical College Hospital,Sarjapur Road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  919764062212  
Fax    
Email  mathangidoc@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mathangi Krishnakumar 
Designation  Assistant Professor Department of Anaesthesia 
Affiliation  St John’s Medical College Hospital 
Address  Surgical and Neuro Intensive Care unit,2nd Floor St John’s Medical College Hospital,Sarjapur Road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  919764062212  
Fax    
Email  mathangidoc@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Mathangi Krishnakumar 
Designation  Assistant Professor Department of Anaesthesia 
Affiliation  St John’s Medical College Hospital 
Address  Surgical and Neuro Intensive Care unit,2nd Floor St John’s Medical College Hospital,Sarjapur Road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  919764062212  
Fax    
Email  mathangidoc@outlook.com  
 
Source of Monetary or Material Support  
Epsilon Medical Devices Sdn Bhd. Lot 5271, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting, Perak, Malaysia 
 
Primary Sponsor  
Name  Epsilon Medical Devices Sdn Bhd. 
Address  Lot 5271, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting, Perak, Malaysia 
Type of Sponsor  Other [Medical devices and components manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mathangi Krishakumar  St John’s Medical College Hospital  Surgical and Neuro Intensive Care unit,2nd Floor St John’s Medical College Hospital,Sarjapur Road Bengaluru
Bangalore
KARNATAKA 		 9764062212

mathangidoc@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,St. John’s Medical College Hospital bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J98||Other respiratory disorders, (2) ICD-10 Condition: Z930||Tracheostomy status,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Heat and Moisture Exchange filters and humidifiers  Heat and Moisture Exchangers (HME) are intended to replace the normal warming and humidifying the upper airways of tracheal-intubated patient. The media that form the components are in the forms of Techno stat filter or foam inserts which are embedded with a hygroscopic salt such as calcium chloride. The device is placed between the patient and the breathing system. Expired gas cools as it crosses the membrane, resulting in condensation. During inspiration, the absorbed heat evaporates the condensate and warms the gas, while the hygroscopic salt releases water molecules when the vapor pressure is low. The warming and humidification are thus regulated by the moisture content of the expired gas and patients core temperature. The total expected duration of the clinical investigation is 5 months. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
1)Adults (≥18 years) requiring mechanical ventilation for ≥24 hours.
2)Informed consent from the Legally Authorized Representative (LAR). 
 
ExclusionCriteria 
Details  Exclusion Criteria
1)Significant pre-existing lung disease. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Airway humidity levels as measured by digital psychrometry.  The total duration of the study:3 months
Time taken for each subject (if it involves interviews, follow up period):There is no follow-up involved in this study
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of device-related adverse events.
2.Changes in ventilatory parameters, including peak airway pressures.
3.Occurrence of ventilator-associated pneumonia (VAP).
 		 The total duration of the study:3 months
Time taken for each subject (if it involves interviews, follow up period):There is no follow-up involved in this study 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) 17/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Title of the Study: A prospective study to assess the safety and efficacy of Heat and Moisture Exchange filters and humidifiers in Mechanically Ventilated Patients.
Primary Objective:
To evaluate the efficacy of HME filters in maintaining airway humidity.
Secondary Objective:
To assess the safety of HME filters by monitoring device-related adverse events.
To measure changes in ventilatory parameters and respiratory mechanics.
Duration of the study: 
a. The total duration of the study: 
3 months
b. Time taken for each subject (if it involves interviews, follow up period):
There is no follow-up involved in this study
Sample Size:
sample size of 90 for this study is determined based on statistical considerations to ensure adequate power for detecting clinically significant differences in the safety and efficacy outcomes of Heat and Moisture Exchange (HME) filters and active humidifiers in mechanically ventilated patients. 

Results of study-
The clinical study of all tested variants, including EMD-HVF-S, EMD-HVF-B, EMD-HS-1, EMD-HS-2, EMD-HCH04, and EMD-HCHV6, demonstrated consistent and reliable performance in maintaining tracheal humidity, temperature, and airway pressure across 15 patients per variant, totaling 90 patients. All variants effectively ensured optimal humidification, filtration, and secretion barriers, maintaining stable and safe conditions throughout the study period. 

The overall product experience, evaluated by the Principal Investigator (PI), reflected high satisfaction, with most ratings categorized as Excellent and Very Good. No risks, side effects, or adverse events were observed during the study, further supporting the safety, effectiveness, and clinical benefits of the evaluated product variants. These findings confirm that the devices met clinical expectations and delivered consistent, reliable performance


conclusion-

The clinical evaluation of six device variants: EMD-HVF-S, EMD-HVF-B, EMD-HS-1, EMD-HS-2, EMD-HCH04, and EMD-HCHV6, across a total of 90 patients (15 per variant), demonstrated consistently favorable outcomes in alignment with the predefined study endpoints. 

The primary endpoint, measurement of airway humidity using digital psychrometry, confirmed that all variants successfully maintained optimal tracheal humidity and temperature levels throughout the 24-hour observation period. This highlights the effectiveness of the devices in delivering consistent humidification, which is critical for patient safety during mechanical ventilation. 

Regarding the secondary endpoints: 

Ventilatory parameters, including peak airway pressures, remained stable across all variants, with only minor, clinically acceptable fluctuations observed, indicating effective ventilatory performance. 

No device-related adverse events were reported, underscoring the safety profile of each product. 

No cases of ventilator-associated pneumonia (VAP) were observed during the study, suggesting that the devices provided an effective barrier against infection. 

 Additionally, performance feedback collected from the PI using a five-point Likert scale indicated high satisfaction across key parameters, including filtration efficiency, humidification, secretion barrier function, and ease of use. The majority of ratings were categorized as Excellent, with no instances of poor performance. 

In summary, the study confirms that all tested variants are safe, effective, and clinically reliable, meeting the intended performance criteria and supporting their continued use in ventilated patients. 

 
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